Manufacturing Oversight: How FDA Ensures Generic Drug Safety
Explore how the FDA ensures generic drug safety through rigorous manufacturing oversight, bioequivalence testing, and global inspections under the Hatch-Waxman Act and GDUFA frameworks.
Tag: Hatch-Waxman Act
Hatch-Waxman Amendments: How Landmark Law Made Generic Drugs Possible
The Hatch-Waxman Act of 1984 created the legal framework that made generic drugs possible in the U.S., cutting costs by up to 90% and boosting access to affordable medicine. Here's how it works-and why it still matters today.
